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Health Canada/FDA ApprovedUnited States, Canada

New Pill for a Gene-Related Advanced Lung Cancer

Hyrnuo (sevabertinib) for HER2 TKD-mutant NSCLC

The FDA and Health Canada have labelled an oral HER2 tyrosine-kinase inhibitor for adults with locally advanced or metastatic NSCLC whose tumours have HER2 (ERBB2) tyrosine kinase domain activating mutations after prior

FDA ApprovedUnited States

Monthly Shot to Lower Triglycerides and Pancreatitis Risk

Tryngolza (olezarsen) — ApoC-III ASO for severe hypertriglyceridemia (sHTG) and FCS

This is for adults with severe hypertriglyceridemia (fasting TG 500 mg/dL or higher) — and caregivers — who need a labelled way to lower triglycerides and cut the risk of acute pancreatitis, and for…

FDA ApprovedUnited States

Once-Daily Pill for FOP Bone Growth in Teens and Adults

Atebrioz (zilurgisertib) — oral ALK2 inhibitor to reduce new heterotopic ossification in FOP (ages 12+)

This is for teens 12 and older and adults with fibrodysplasia ossificans progressiva (FOP) — and caregivers — who need a labelled way to slow new extra bone (heterotopic ossification). It explains…

FDA ApprovedUnited States

New Oral Pill Option for Previously Treated Bile Duct Cancer

Lyrfigtu (lirafugratinib) — oral FGFR2 inhibitor for previously treated FGFR2-altered cholangiocarcinoma

This is for adults with previously treated unresectable, locally advanced, or metastatic bile duct cancer (cholangiocarcinoma) that harbors an FGFR2 gene fusion or other rearrangement — and the…

Breakthrough Brief

New treatments and trials, weekly. Every email has an unsubscribe link.

Special series

Breaking Out: The Weight Class — Shots, Pills, and Organ Labels in 2026

Shots, pills, and organ labels in the 2026 weight class — Wegovy injection, Zepbound, the oral maze, and the process line that authorized is not funded. International by default. Zoom by country. Authorized is not funded.

Enter the seriesAll series

Treatment types

The next wave of treatment

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Gene Therapy

8 pieces

Cell Therapy

2 pieces

GLP-1

2 pieces

Glucagon-like peptide-1 (and dual GIP/GLP-1) medicines for diabetes, weight, and labelled organ-protection uses. Authorized is not funded.

More breakthroughs

NewestPatient Stories
FDA ApprovedUnited StatesEuropean Union

Once-Weekly Basal Insulin Shot for Adults with Type 2 Diabetes

Onswik (insulin efsitora alfa-gobe) — once-weekly basal insulin for adults with type 2 diabetes

This is for adults with type 2 diabetes — and caregivers helping them — who may be candidates for a once-weekly basal insulin instead of a daily basal shot. It explains FDA approval of Onswik…

EMA AuthorisedEuropean Union

First EU Medicine for Early Brain ALD in Boys Ages 2–12

Nezglyal (leriglitazone) — oral suspension for early cerebral adrenoleukodystrophy (Gd-negative)

This is for boys aged 2 to 12 with early cerebral adrenoleukodystrophy (cALD) — Gd-negative brain lesions on MRI and a Neurological Functional Score of 0 or 1 — and the caregivers helping them. It…

FDA ApprovedUnited States

New Prescription Ointment for Mild-to-Moderate Eczema Ages 2 and Up

Adquey (difamilast) — topical ointment for mild-to-moderate eczema (atopic dermatitis)

This is for people with mild to moderate atopic dermatitis (eczema) — and caregivers of children 2 years and older — who may be candidates for labelled US Adquey ointment. It explains the…

FDA ApprovedUnited StatesEuropean Union

First FDA-Approved Treatment for MCT8 Peripheral Thyrotoxicosis

Emcitate (tiratricol) — dispersible tablets for peripheral thyrotoxicosis in MCT8 deficiency

This is for people living with MCT8 deficiency (Allan-Herndon-Dudley syndrome) — and the caregivers who help them — who need an honest path to tiratricol. It explains the first FDA-approved US…

FDA ApprovedUnited States

Ameluz Red-Light PDT Now FDA-Approved for Superficial Basal Cell Skin Cancer

Ameluz (aminolevulinic acid HCl 10% gel) — red-light PDT for superficial basal cell carcinoma

This is for adults with superficial basal cell carcinoma — and the caregivers helping them — who may be candidates for labelled US Ameluz red-light PDT with a BF-RhodoLED or RhodoLED XL clinic lamp.…

FDA ApprovedUnited States

First FDA-Approved Implant Treatment for MacTel Eye Disease

Encelto (revakinagene taroretcel-lwey) — encapsulated cell implant for macular telangiectasia type 2

This is for adults living with idiopathic macular telangiectasia type 2 — and the caregivers who help them — who may be candidates for labelled US Encelto encapsulated cell implants at a…

FDA ApprovedUnited States

First FDA-Approved Treatment for Ataxia in Ataxia-Telangiectasia

Aqneursa (levacetylleucine) — oral suspension for ataxia in ataxia-telangiectasia

This is for people living with ataxia-telangiectasia — and the caregivers who help them — who weigh at least 15 kg and may be candidates for labelled US Aqneursa oral suspension for ataxia. It…

FDA ApprovedUnited States

First FDA-Approved Gene Therapy for AADC Deficiency

Kebilidi (eladocagene exuparvovec-tneq) — one-time intraputaminal gene therapy for aromatic L-amino acid decarboxylase deficiency

This is for families of children (and adults) with genetically confirmed AADC deficiency from biallelic DDC changes who have achieved skull maturity and may be candidates for labelled US Kebilidi…

FDA ApprovedUnited States

First FDA-Approved Gene Therapy Sheets for RDEB Wounds

Zevaskyn (prademagene zamikeracel) — gene-modified cellular sheets surgically applied to treat wounds in recessive dystrophic epidermolysis bullosa

This is for people living with recessive dystrophic epidermolysis bullosa — and the caregivers who help them — who have chronic open wounds and may be candidates for labelled US Zevaskyn autologous…

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